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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Medtronic
UBS
Chinese Patent Office
Chubb
Queensland Health
Farmers Insurance
Cantor Fitzgerald
Express Scripts

Generated: August 20, 2018

DrugPatentWatch Database Preview

KYPROLIS Drug Profile

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Which patents cover Kyprolis, and what generic alternatives are available?

Kyprolis is a drug marketed by Onyx Therap and is included in one NDA. There are eleven patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and eighty-eight patent family members in thirty-six countries.

The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.

Drug patent expirations by year for KYPROLIS
Generic Entry Opportunity Date for KYPROLIS
Generic Entry Date for KYPROLIS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for KYPROLIS
Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors
Synonyms for KYPROLIS
(2S)-4-methyl-N-[(2S)-1-[[(2S)-4-methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]-2-[[(2S)-2-[(2-morpholin-4-ylacetyl)amino]-4-phenylbutanoyl]amino]pentanamide
(2S)-N-((1S)-1-Benzyl-2-(((1S)-3-methyl-1-(((2R)-2-methyloxiran-2-yl)carbonyl)butyl)amino)-2-oxoethyl)-4-methyl-2-(((2S)-2-((morpholin-4-ylacetyl)amino)-4-phenylbutanoyl)amino)pentanamide
(2S)-N-[(1S)-1-benzyl-2-[[(1S)-3-methyl-1-[(2R)-2-methyloxirane-2-carbonyl]butyl]amino]-2-oxo-ethyl]-4-methyl-2-[[(2S)-2-[(2-morpholinoacetyl)amino]-4-phenyl-butanoyl]amino]pentanamide
(Alphas)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-l-leucyl-n-((1s)-3-methyl-1-(((2r)-2-methyloxiranyl)carbonyl)butyl)-l-phe nylalaninamide
(alphas)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-l-leucyl-n-((1s)-3-methyl-1-(((2r)-2-methyloxiranyl)carbonyl)butyl)-l-phenylalaninamide
(S)-4-methyl-N-((S)-1-(((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-yl)amino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)pentanamide
(S)-4-Methyl-N-((S)-1-((S)-4-Methyl-1-((R)-2- Methyloxiran-2-yl)-1 -oxopentan-2-ylaMino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-MorpholinoacetaMido)-4-phenylbutanaMido)pentanaMide
72X6E3J5AR
868540-17-4
AB0008111
AB01565867_02
AC-27051
AKOS025401910
AN-217
AOB87759
AS-17059
BC251806
BDBM50277889
BLMPQMFVWMYDKT-NZTKNTHTSA-N
C40H57N5O7
Carfilzomib
Carfilzomib (JAN/USAN/INN)
Carfilzomib (PR-171)
Carfilzomib [USAN:INN]
Carfilzomib?PR-171?/Kyprolis
Carfilzomib(PR171)
CAS-868540-17-4
CHEBI:65347
CHEMBL451887
CS-0984
CS-W004540
D00UVA
D08880
DB08889
DSSTox_CID_28616
DSSTox_GSID_48690
DSSTox_RID_82886
DTXSID4048690
FT-0696769
GTPL7420
HY-10455
J-501773
KB-75946
KS-00000SR1
Kyprolis (TN)
L-Phenylalaninamide, (alphaS)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-L-leucyl-N-((1S)-3-methyl-1-(((2R)-2-methyloxiranyl)carbonyl)butyl)-
MFCD11040997
MLS006011102
MolPort-027-950-907
N-{(2S)-2-[(morpholin-4-ylacetyl)amino]-4-phenylbutanoyl}-L-leucyl-N-{(2S)-4-methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl}-L-phenylalaninamide
NCGC00249613-01
NCGC00249613-02
NCGC00249613-03
ONO-7057
PR 171
PR-171
PX-171-007
QCR-96
RL05381
S-7798
s2853
SC-91032
SCHEMBL85165
SMR004660024
SR-01000941582
SR-01000941582-1
Tox21_113079
Tox21_113079_1
UNII-72X6E3J5AR
Y0441
ZINC49841054

US Patents and Regulatory Information for KYPROLIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-003 Jun 7, 2018 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for KYPROLIS
Drugname Dosage Strength RLD Date
➤ Subscribe For Injection 30 mg/vial ➤ Subscribe ➤ Sign Up
➤ Subscribe For Injection 60 mg/vial ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for KYPROLIS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,198,270 Compounds for proteasome enzyme inhibition ➤ Sign Up
8,088,741 Compounds for enzyme inhibition ➤ Sign Up
8,324,174 Compounds for enzyme inhibition ➤ Sign Up
8,207,124 Compounds for enzyme inhibition ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for KYPROLIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016010,C1781688 Lithuania ➤ Sign Up PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
015 Luxembourg ➤ Sign Up PRODUCT NAME: CARFILZOMIB EVENTUELLEMENT SOUS FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; FIRST REGISTRATION: 20151123
16/013 Ireland ➤ Sign Up PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/15/1060 20151119
0805 Netherlands ➤ Sign Up PRODUCT NAME: CARFILZOMIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1060 20151123
C0017 France ➤ Sign Up PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: EU/1/15/1060 20151123
0160008 00189 Estonia ➤ Sign Up PRODUCT NAME: KARFILSOMIIB;REG NO/DATE: EU/1/15/1060 23.11.2015
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Cipla
Covington
Dow
Cantor Fitzgerald
McKinsey
Johnson and Johnson
UBS
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.